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ClinicalTrials.gov Identifier: NCT00656851

Recruitment Status
:
Completed

First Posted
: April 11, 2008

Results First Posted
: August 20, 2013

Last Update Posted
: August 28, 2013

Sponsor:

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Key information relevant to the recruitment process for the
overall study, such as dates of the recruitment period and locations

Twenty four participants were enrolled from the AIDS Clinical Trials Unit and Infectious Diseases Clinics at Washington University School of Medicine in St. Louis, Missouri, USA. This was a prospective, two-group, random assignment study.

Pre-Assignment Details

Significant events and approaches for the overall study
following participant enrollment, but prior to group assignment

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

Limitations of the study, such as early termination leading to small numbers of participants
analyzed and technical problems with measurement leading to unreliable or uninterpretable data

We did not perform the myocardial metabolic measurements under insulin-stimulated conditions (i.e. hyperinsulinemic clamps). Small number of participants and high measurement variability, efficacy was not found. Study ended to minimize risk/benefit.